CoRoent 7151050Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517231390), received between Apr 20, 2017 and Jul 11, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER TAKING FINAL X-RAYS FOLLOWING A LEFT-SIDED L4-L5 EXTREME LATERAL INTERBODY FUSION, THE SURGEON NOTICED BLEEDING. A DRAIN WAS INSERTED; HOWEVER, AN UNKNOWN VOLUME OF BLOOD WAS LOST AND A TRANSFUSION WAS REQUIRED. THE PATIENT WAS TRANSFERRED TO THE ICU.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14980651 ↗
• MalfunctionApr 20, 2017Migration or Expulsion of Device; Failure to Osseointegrate; Migration or Expulsion of Device; Failure to Osseointegrate

  PATIENT UNDERWENT A LATERAL INTERBODY FUSION PROCEDURE AT L2-3 ON (B)(6) 2016. A PEEK INTERBODY CAGE WAS IMPLANTED WITH ADDITIONAL FIXATION HARDWARE. IN ADDITION, A BONE GRAFT WAS PLACED INSIDE THE CAGE AND IN THE POSTERIOR LATERAL GUTTERS. ONE YEAR AFTER INDEX SURGERY, RADIOGRAPHS INDICATED L2-3 HAS NOT FUSED AND THE CAGE HAS MIGRATED ANTERIORLY. THE PATIENT REPORTED SIGNIFICANT PAIN. NO INJURY HAS BEEN REPORTED.

  Patient problems: Pain

  MAUDE report 6509951 ↗